ISO 13485 Training Courses
There is probably no other industry where the importance of product conformity is as crucial as that in the design and manufacture of medical devices. Standards in any industry are an important way both to safeguard product conformity while simultaneously harmonizing requirements, not only nationally, but internationally as well.
An important step in safeguarding product conformity and ensuring that a manufacturing or design process can consistently produce product of the required standard, is a structured management system. With regards to medical devices, there is no standard that better represents the requirements for a comprehensive management system than ISO 13485. Compliance with ISO 13485 is often seen as the first step in achieving compliance with regulatory requirements.
Increasingly, certification to ISO 13485 is becoming the preferred method for medical device manufacturers and their sub tier suppliers/contractors to demonstrate the intent to comply with applicable regulatory and statutory requirements. Medical device manufacturers who are placing their products on the market within the European Union will need to address compliance with the requirements of the applicable Medical Device Directive and the CE marking process. ISO 13485 is recognized as an aid in supporting compliance with the MDD.
Public Training – Where You Come To Us
CQI & IRCA Certified ISO 13485:2016 Lead Auditor Certification Training Course
We offer a comprehensive five-day ISO 13485:2016 lead auditor training course is based on assisting and verifying the competencies/capabilities of the Learner to be able to effectively audit a complete QMS based on ISO 13485:2016 requirements with specific emphasis of 2nd Party auditing [Customer/Supplier audits] and 3rd Party auditing [Certification Bodies].
Days : 5
Course Type : Auditor Courses
Certification : CQI & IRCA Certified Course (A18242)
Price : $ 2495.00
Onsite Training – Where We Come to You
ISO 13485:2016 Requirements Awareness Training Course
The focus of the Kelmac Group® QMS Fundamentals based on ISO 13485:2016 Training Course is to comprehensively introduce Learners to Quality Management Systems and provide them with a highly insightful introduction to the purpose, intent and requirements of ISO 13485 plus the business case for adopting ISO 13485.
Days : 1
Course Type : Understanding Courses
Certification : Kelmac Group Certified Training Course
ISO 13485:2016 Internal Auditor Training Course
The focus of the Kelmac Group® ISO 13485:2016 Internal Auditor Classroom Learning Course is on assisting and verifying the competencies/capabilities of the Learner to be able to effectively audit a product, process or department/function of a QMS based on ISO 13485:2016 requirements with specific emphasis of 1st Party auditing [Internal audits].
Days : 2
Course Type : Auditor Courses
Certification : Kelmac Group® Certified Course
All Our Training Is Available In HouseCan’t come to us?
WE CAN COME TO YOU
WE CAN COME TO YOU
- Available Nationwide
- Tailored to you
- Fixed Fees, No Expenses*
- Groups of 5+
*Only available in IL, T&Cs apply
The Ultimate Business Training Experience
The Kelmac Group® has developed a unique tradition of creating learning services that shape the future of conformity and compliance learning solutions for Executive Management, Practitioners and Auditors. Where others train followers, we train leaders™
Others Train Followers. We train leaders.™
At Kelmac Group®, we have proven, real world experience in serving a broad range of industries which includes:
The quality of our Instructors is the cornerstone of our ability to serve our clients. Our people have real world practical experience and inspire confidence with Learners
We offer the lowest and most sustainable system maintenance money can buy.
We are one of the few to objectively focus on and measure individual competency before, during, and post-delivery. Many competitors make claims; we show results.
No Death by Power Point
Many training courses have a high focus on PowerPoint slides and information loading. We provide Learners with the tools to grow, learn and become Leaders.
No other training provider in Ireland has more training accreditations across a broader scope than Kelmac Group. Fact!
Having worked in over 35 countries, we have experience that matters. A wealth of knowledge to share that is invaluable during training for those looking to learn from the best.
History of Innovaton
We have a history of listening and a proven history of introducing many of the world’s first offerings on the market, including online & combined training courses.
Unlike competitors who ‘cherry pick’ testimonials, we publish student reviews of our training from every course that we run. This gives you real and honest feedback about us.
IRCA Certified FSSC 22000 Lead Auditor Training Course
Another successful IRCA Certified FSSC 22000 Lead Auditor Training Course took place last week in Chicago and Kelmac Group® would like to take this time to thank all who attended and helped make it such a success. We hope you had as much fun with the learning experience as we did delivering it. The IRCA … Continue reading IRCA Certified FSSC 22000 Lead Auditor Training CourseRead More
Limerick-founded SME Kelmac Group collaborates with Lero on a €280,000 R&D Project
Limerick-founded SME Kelmac Group collaborates with Lero on a €280,000 R&D project to transform it into global internet player– Kelmac Group® to double Irish workforce and open international R&D technology centre at Plassey Technological Park, Limerick Limerick, Wednesday, 8th February, 2017: Kelmac Group®, a Limerick based standards and compliance company, is collaborating with Lero, the Irish … Continue reading Limerick-founded SME Kelmac Group collaborates with Lero on a €280,000 R&D ProjectRead More
ISO 14001 – Your Organization, Your Environment
ISO 14001 is the world most popular environmental management system standard. As of 2013 it is currently implemented by 301,647 organisations worldwide, so it must obviously work and its voluntary! Environmental management is all about how a company interacts with the environment and how it manages that interaction. It’s where the company figures out how it interacts with the environment and decides how best to control and manage its products, services and activities that affect the environment. In simple terms, ISO 14001:2004 is about putting a structured management approach in place that lets you identify your interactions (aspects and impacts), figure out which ones need to be managed closely (significant aspects),…Read More